# K133100: Carefine Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Facet Technologies
- Decided: Jan 23, 2014 after 115 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951254 (1995). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100812: Ulticare Disposable Pen Needles, Ultimed, Inc. (2010) Summary page 3.
- K090111: Flexpen Needle, Novo Nordisk, Inc. (2010) Summary page 3.
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010) Summary page 3.

## Most influential descendants
- K140568: Carefine Pen Needle with Quintapoint and Superpoint (2014), 1 descendant of its own
- K171144: Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel (2017), 0 descendants of its own
- K141749: Carefine Pen Needle Family Including Quintapoint and Superpoint (2014), 0 descendants of its own

## Indications for use
The CareFineTM Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K133100
Methodology: https://510kreport.com/methodology